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RECRUITING
NCT05387603
PHASE3

Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.

Sponsor: Lund University Hospital

View on ClinicalTrials.gov

Summary

There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized. This trial aims to compare personalized PRRT to non-personalized PRRT in terms of safety, efficacy and resource demands in order to optimize treatment outcomes in an evidence-based manner in future.

Official title: Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. An Open-label, Multicenter, Randomized Phase III Trial Comparing Safety and Efficacy of Personalized Versus Non-personalized Radionuclide Therapy With 177Lu (Lutetium)-DOTATOC.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2022-11-01

Completion Date

2026-10-01

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

DRUG

177Lu-DOTATOC

The investigational medicinal product (IMP) is 177Lu-DOTATOC which is registered as an orphan drug by the EMA ( European Medicines Agency) for the treatment of GEP-NEN (gastro-entero-pancreatic neuroendocrine tumor). The IMP will be administered to participants both in the control arm and the experimental arms, but with different intervals, but the same activity; 7.5 Gbq per dosing.

DRUG

Capecitabine

Will be given orally with a dose of 825/m2 twice daily, starting on day 1 of each of the 4 first treatment cycles, cycle length 3 weeks.

Locations (4)

Sahlgrenska University Hospital, Dept. of Oncology

Gothenburg, Sweden

Skåne University Hospital, Dept. of Oncology

Lund, Sweden

Karolinska University Hospital, Dept. of Oncology

Stockholm, Sweden

Accademical Hospital, Uppsala, Dept. of Oncology

Uppsala, Sweden